We are looking for a new “QA/CSV Specialist” who will offer service to a multinational pharmaceutical company.
Sant Cugat (Barcelona)
- Support the team in order to ensure that processes within computerized systems (e.g. ERP (SAP), Trackwise)
are implemented and used in a compliant manner (GxP) following internal and external regulations.
- Approval of System Life Cycle documentation in compliance to the respective validation methodology.
- Support deployment according to the BI internal standard method.
- Ensure audit readiness and supports regional audits of systems in scope of the position.
- Regional interactions with all relevant business units (i.e. Production sites and commercial sites) and Global Functions, as well as cross functional project teams.
- Support the handover of quality tasks to the run organization.
- Support that further externals which supporting other internal department(s) are working under the agreed methodology.
- Guides and defines work packages for external support and monitors the quality of deliverables.
- Partner with and educate business stakeholders and cross functional project teams through coaching and education regarding the need for compliance with regulations and quality management processes.
- Manage existing/additional SOPs where applicable.
- Profound experience in a GxP regulated environment with focus on quality assurance and business process expertise.
- Knowledge on Computer System Validation, cGMP regulations and pharmaceutical QA systems –
including external regulations e.g. EU-GMP Guideline, Annex 11, 21 CFR Part 11, Data Integrity requirements and internal regulations.
- Speak-up mentality/ ability to challenge and make judgment calls with Senior Management.
- Ability to prioritize and to effectively manage multiple tasks at the same time, quickly respond to changing internal and external requirements.
- Respect and understanding of cultural diversities across the area of responsibility.
- Fluent in English.
- From monday to friday: 08am to 5pm / 09am to 6pm (flexible)
- During COVID – Full time remote.
- After COVID – Mandatory minimum 3 days of office work.
- Salary package based on your profile.
- Food expenses and Ticket restaurant included in-office hours.
- Flexible compensation plan (free of income tax) where we provide you with medical insurance, public transport ticket and childcare check.
- Discounts on physiotherapy center and gym network.
- Training catalogue.
Our goal is that you are well in every way!